About the Role:
Provide technical support to the BDS and BDP manufacturing areas – leading and supporting troubleshooting and investigations into safety, quality and downtime issues.
Monitor and trend production processes and lead continuous improvement projects through to successful implementation.
Support development work, technical transfer activities (including scale-up) internally and externally, and key projects within the manufacturing function.
This role will develop and maintain critical business relationships internally with various cross functional departments – Manufacturing Operations, QA, QC, QAV, Supply Chain, Botanical, Technical R&D, Operations, Project Management Office (PMO), Procurement, Quality Control (QC), Regulatory Affairs and Supply Chain.
Quality is a primary focus to ensure all aspects of current Good Manufacturing Practices (cGMP) are met and product quality is not compromised. The workload is varied with the core areas of responsibility listed below:
- Where quality, safety and downtime issues arise, lead/ support the investigations using RCA tools. Document the investigation and CAPA’s as per site procedures. Resolve problems of a diverse scope and nature, selecting appropriate problem solving tools, and methods and techniques for obtaining solutions e.g. 6-step RCA, process mapping, Pairwise analysis, Solutions matrix etc.
- Deliver Corrective and Preventative actions.
- Lead/ support project work in manufacturing areas including generation and execution of key area documents including Change Controls, PTPs, Risk Assessments (Quality & Safety), Protocols/ Reports, equipment and process qualification documentation, Standard Operating Procedures (SOPs), Batch documentation, and Training Modules.
- Lead and Support Continuous Improvement Initiatives to improve processes, cost of goods, reducing waste etc. Ensure that the business benefit is quantified and effectiveness review completed. Share best practice across the Production department and OE.
- Generate periodic trending reports through analysis and trending of production data
- Work in cross functional teams to achieve objectives above including working closely with Manufacturing, Engineering, QA, EHS and Supply Chain.
- Be responsible for supporting development work and transitioning BDS/API/ BDP processes from Research & Development (R&D) into the Production Department.
- Support key manufacturing projects as required.
- Support the delivery of company/site objectives to the required Quality, Regulatory and EHS standards.
1) Work to help ensure that all manufacturing and related activities are performed in accordance with all relevant internal/external quality and safety standards. Help to ensure that the Production area is “audit ready” and compliant at all times.
2) As an employee trained in the principles of validation, assist, lead and/or support facility and equipment Commissioning and Qualification activities.
3) Look to ensure continuous improvement of all Production activities, share best practice across the Production department and wider organisation where possible; lead the implementation of new process improvements.
4) Assist/lead the successful implementation of approved projects and associated business plans within the Production area (including technical transfer projects). This will be achieved by:-
- Delivery of all client/group actions in a timely manner to ensure project delivery on time.
- Technical input where required ensuring project success.
- Attend/ chair meetings as technical support as required.
- Use project management tools such as Project Charters, RACI, project planning/ scheduling, dashboards to initiate and manage project work.
- Ensure status of key projects is communicated to sponsors and stakeholders.
5) Generation and review of key area documents, including Standard Operating Procedures (SOPs), Deviations, CAPAs, Change Controls, Risk Assessments, Training Modules, Technical Protocols/Reports and Validation Protocols/Reports.
6) Execution of commissioning, qualification and process validation protocols.
- Collaborates and builds strong network with peers, other functional groups (e.g. QA, SC, Engineering & EHS) and participates in cross functional projects and investigations. Collaborates with external suppliers/ vendors as required for project work.
- Communicates with key stakeholders and project sponsors for project status updates.
Health and Safety and risk assessment:
- To assist by example on safety issues by following procedures and reporting safety issues
- To ensure that accidents and near misses in their areas are reported
- To assist employees in the Production related areas have the relevant instruction and training to perform their jobs safely for new processes or equipment.
- To ensure that any new control measures introduced are explained to employees and implemented
- To assist their manager in identifying activities posing a significant risk to employees in their departments so that they can be assessed
- To assess hazards in their areas to the best of their knowledge and propose any additional control measures needed to reduce risks and mitigate the potential outcome of accidents
- Qualification to degree standard in Pharmaceutical, Physical Science or Process engineering discipline.
- Good knowledge of cGMP and FDA and MHRA expectations.
- A minimum of 5 years’ knowledge gained from working in a Pharmaceutical Production/Development or other regulated industry is essential
- Evidence of technical ability and understanding of the processes relating to Pharmaceutical production
- Proven Technical ability.
- Working knowledge of all core Microsoft packages, i.e. Word, Excel, Power Point etc.
- High level of numeracy
- Communication skills including written and presentational
- Excellent attention to detail
- Interpret data
- Good technical knowledge and scientific understanding of the processes used in the manufacture, filling and packing process and the scientific basis.
- Technical writing skills.
Attributes and Behaviours:
- Develops and maintains positive working relationships with others
- Shares ideas and information
- Assists colleagues as and when required
- Demonstrates a ‘can do’ approach
- Ability to work under pressure and to deadlines
- Able to operate independently, as well as working effectively within a team.
- A great balance of technical, commercial and people skills
- Ability to find “win-win” outcome when faced with difficult challenges/conflict.
- Experience of completing Continuous Improvement projects.
- Experience of commissioning and validation activities.
- Experience in Operation Excellence
- Experience in use of statistical tools and applications e.g. minitab
Unlock the potential of cannabinoid science to transform the lives of the patients and their families
Lead the world in developing and commercialising regulatory approved cannabinoid medicines, putting patients first
Our efforts are guided by several fundamental values. At all times we strive to be:
Patient Driven – We never forget who we're striving for
Passionate – We are here to change lives
Innovative – We challenge ourselves to find new and better approaches
Collaborative – We accomplish more through working together and valuing one another
Accountable – We take responsibility and deliver on our commitments
Integrity – We are fair, honest, and ethical
Excellence – We pursue the highest standards for ourselves and for our industry
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